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NCT01162681 · ClinicalTrials.gov registry record · Phase 2

PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus

A Phase 2 study, sponsored by Anthera Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
547
Enrollment target

NCT01162681: Completed Phase 2 study, sponsored by Anthera Pharmaceuticals.

NCT01162681 is a Phase 2 study that has completed, run by Anthera Pharmaceuticals. The registered enrollment target is 547 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (311% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01162681, a Phase 2 study, has completed, sponsored by Anthera Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
547 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease

Primary Outcome

The % of subjects with SLE response compared with baseline at the time of assessment

Interventions

  • OTHER Placebo Comparator
  • DRUG A-623

Trial Details

FieldValue
Enrollment Target 547 participants
Start Date 2010-07
Est. Completion 2012-04
Phase Phase 2
Anthera Pharmaceuticals

16 total trials

What the finished NCT01162681 record still lists

NCT01162681 is an interventional study that assigns participants to a tested intervention. The registered 547 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (311% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator is the first listed.

NCT01162681 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01162681 about?

NCT01162681 is a clinical study titled "PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus". The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease

What is the current status of trial NCT01162681?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 547 participants. The study started on 2010-07. Estimated completion is 2012-04.

What interventions are being tested in trial NCT01162681?

The interventions under investigation include: Placebo Comparator (OTHER), A-623 (DRUG).

Who is sponsoring clinical trial NCT01162681?

This trial is sponsored by Anthera Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01162681's enrollment target sits among peer trials

547 62nd of 2000 higher than 1,939 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01162681, the US trial registry maintained by the National Library of Medicine. NCT01162681 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.